地塞米松棕榈酸酯注射液治疗急性痛风性关节炎的临床疗效和安全性研究  

Clinical efficacy and safety of dexamethasone palmitate injection in the treatment of acute gouty arthritis

作　　者：招淑珠 郭紫石 于清宏[4] 邱敏丽[1] 杨明灿[1] 祁军[1] 曹双燕[1] 成红英 古洁若[1] Zhao Shuzhu;Guo Zishi;Yu Qinghong;Qiu Minli;Yang Mingcan;Qi Jun;Cao Shuangyan;Cheng Hongying;Gu Jieruo(Department of Rheumatology and Immunology,the Third Affiliated Hospital of Sun Yat-sen University,Guangzhou 510630,China)

机构地区：[1]中山大学附属第三医院风湿免疫科,广州510630 [2]佛山市南海区人民医院,佛山528200 [3]佛山市禅城区中心医院,佛山528040 [4]南方医科大学珠江医院,广州510280

出　　处：《新医学》2018年第11期821-827,共7页Journal of New Medicine

摘　　要：目的探讨地塞米松棕榈酸酯(DXP)注射液静脉注射治疗急性痛风性关节炎的临床疗效和安全性。方法设计为多中心、阳性药物对照、随机的临床研究,选择3家医院的70例急性痛风性关节炎患者,随机分为试验组和对照组,每组各35例。试验组静脉注射DXP注射液1 ml,对照组肌内注射复方倍他米松注射液1 ml,研究为期14 d,在治疗前和治疗后第7日及14日对患者进行评估,比较2组在治疗前后及组间的疗效指标差异,其中主要疗效指标为受累关节疼痛视觉模拟评分(VAS),次要指标为受试者对疾病总体状况的VAS、超声下关节积液深度和滑膜厚度及血流信号、受试者自我评价、关节压痛指数、CRP、ESR,同时记录2组患者在研究期间发生的不良事件。结果治疗后第7日和第14日,2组患者的受累关节VAS、疾病总体状况VAS、CRP和ESR均低于同组治疗前(P均<0.01),关节积液深度、关节压痛指数均较治疗前改善(P均<0.05),2组上述指标组间比较差异均无统计学意义(P均>0.05)。2组患者的关节滑膜厚度、血流信号变化均不明显(P均>0.05)。治疗后第7日,试验组患者对受累关节的自我评价高于对照组(P<0.05)。治疗后第14日,试验组和对照组患者对受累关节的自我评价比较差异无统计学意义(P>0.05)。研究期间2组患者均无发生不良事件。结论 DXP注射液静脉注射治疗急性痛风性关节炎安全、有效,治疗后患者的疼痛症状、关节积液、炎症状态均能得到明显改善。Objective To evaluate the clinical efficacy and safety of intravenous injection of dexamethasone palmitate(DXP)in the treatment of acute gouty arthritis.Method In this multicenter,positive drug control,randomized clinical study,70 patients with acute gouty arthritis from 3 hospitals were enrolled and randomly assigned into the experimental(n=35)and control groups(n=35).In the experimental group,1 ml of DXP was administered via intravenous injection and those in the control group were treated with 1 ml of compound betamethasone via intramuscular injection.The entire study endured for 14 days.Clinical parameters of all patients were evaluated and statistically compared between two groups before,7and 14d after corresponding treatment.The primary index was the visual analogue scale(VAS)score for joint pain.The secondary indexes consisted of the VAS score for subject global assessment,the depth of joint effusion,the thickness and blood signal of synovium detected by color ultrasound,subject selfevaluation,joint tenderness index,Ccreative protein(CRP)and erythrocyte sedimentation rate(ESR).The incidence of adverse reactions was also observed in two groups.Results After 7and 14d treatment,the VAS score for joint pain,VAS score for subject global assessment,CRP and ESR were significantly lower(allP<0.01),and the depth of joint effusion and joint tenderness index were evidently mitigated(bothP<0.05)compared with the results before corresponding treatment in both groups.No statistical significance was observed between two groups in these parameters(allP>0.05).In both groups,the thickness and blood signal of synovium did not significantly change after corresponding treatment(bothP>0.05).After 7d treatment,the selfevaluation score of the affected joint in the experimental group was significantly higher than that in the control group(P<0.05),whereas no statistical significance was noted after 14d treatment(P>0.05).No adverse events are observed throughout the study.Conclusion Intravenous injection of DXP is an efficacious and

关 键 词：地塞米松棕榈酸酯 急性痛风性关节炎 临床疗效 安全性 复方倍他米松 

分 类 号：R589.7[医药卫生—内分泌]